Home›Hong Kong, China SAR›Asahi Intecc Co., Ltd.

Asahi Intecc Co., Ltd.

Hong Kong, China SAR · Hong Kong · www.filmecc.com

✓ Record-verifiedregistrations found in 12 marketsEU SRN JP-MF-000010199

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class IIa 102Class III 198

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

9listed device types

Class I 0Class II 9Class III 0

plus 208 registration records and 85 510(k)

UKUnited KingdomMHRA PARD

19registered device records

Class I 4Class IIa 4Class III 11

BRBrazilANVISA

18registered devices

Class II 18

40 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

5active device licences

Class II 5

35 including historic records

TWTaiwanTFDA

36valid device licences

Class II 36

SGSingaporeHSA SMDR

38device registrations

CLASS D 38

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

23active ARTG entries

Class III 17IIa 3IIb 2Class Is (sterile) 1

HKHong KongMDACS

42valid listings

Class II 9Class IV 33

ILIsraelAMAR

13registrations

RURussiaRoszdravnadzor

4active registrations

Class 2b 1Class 3 3

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union1,622 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States208 registration records, 85 510(k), 0 PMA

United Kingdom19 confirmed, 0 excluded

Brazil18 confirmed, 0 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: ASAHI INTECC (THAILAND) CO., LTD. · ASAHI INTECC CO., LTD. · ASAHI INTECC HANOI CO., LTD. · ASAHI INTECC USA, INC. · ASAHI INTECC CO., LTD · ASAHI INTECC CO.,LTD

Regulatory identity

EU manufacturer SRN: JP-MF-000010199
EU authorised representative: Emergo Europe B.V.
UK responsible person: VASCULAR PERSPECTIVES LIMITED

Business registration

Legal name: ASAHI INTECC CO. LTD.
LEI: 335800UL8W1AH1PBVX60
Registration status: Active
Legal form: 株式会社 (株)
Incorporated: 2014-01-07
Registered address: 14TH FLOOR, TOWER 5B, GURUGRAM, 122002
Registration authority: Companies Register, no. F04683
Registry record updated: 2026-05-04

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

62007

22008

32009

32010

52011

12012

32013

22014

42015

92016

32017

42018

72019

22020

22021

42022

12023

42024

72025

22026

FDA listed device types

showing 8 of 9

Catheter, Peripheral, Atherectomy 1Guide, Wire, Catheter, Neurovasculature 1Endoscopic Guidewire, Gastroenterology-Urology 1Wire, Guide, Catheter 1Catheter, Percutaneous, Neurovasculature 1Snare, Flexible 1Electrode, Electrosurgical, Active, Urological 1Catheter, Percutaneous 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04547327094672	ASAHI Meister 16	Class IIa
EU	04547327094665	ASAHI Meister 16	Class IIa
EU	04547327108256	ASAHI Meister 16	Class IIa
EU	04547327094696	ASAHI Meister 16	Class IIa
UK	35094	ASAHI PCI Guide Wire	Class III
UK	35094	PCI Guide Wire SION	Class III
UK	35094	CHIKAI	Class III
US	K254178	SAYA 86 Radial Access Guide Catheter	2026-05-11
US	K252011	CHIKAI Nexus petit	2026-02-02
US	K251560	FUBUKI XF-R Neurovascular Long Sheath	2025-06-20
BR	80433819007	FIO GUIA PERIFÉRICO ASAHI HIDROFÍLICO + URETANO + SILICONE	Class II
BR	80433819019	FIO GUIA VASCULAR PERIFÉRICO ASAHI CHIKAI V	Class II
BR	80433819020	Microcateter ASAHI Veloute Ponta Reta	Class II
CA	99035	ASAHI ZENYTEEX GUIDING CATHETER	Class II
CA	101489	ASAHI SILVERWAY	Class II
CA	80993	ASAHI CORSAIR MICROCATHETER	Class II